Effect of Radiotherapy Concurrent of TTFields in Patients With Glioblastoma (ECTG001)

Zhongnan Hospital

Status: Unknown

Conditions: Glioblastoma; Glioma

Treatments: Device: TTFields

Study type: Interventional

Funder types: Other

Identifiers

NCT04902586

ZhongnanH ECTG001

Details and patient eligibility

About

TTFields has been approved by the FDA for the treatment of patients with glioblastoma multiforme. However, the clinical effect and safety of radiotherapy concurrent of TTFields is not definite. In this study, the investigators conduct a phase II clinical trial to evaluate the efficacy and safety of this strategy.

Full description

the investigators plan to recruit 30 patients to evaluate the efficacy and safety of this strategy.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• performance status of 0-1 (Eastern Cooperative Oncology Group performance status)
• histologically confirmed glioblastoma
• no cerebrospinal fluid and distant metastatic disease.

Exclusion criteria

• with a history of brain radiotherapy
• severe hepatic and renal dysfunction

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

E group

Experimental group

Description:

All patients received chemoradiotherapy (CRT) ( PTV-GTV: 60Gy at 2.0Gy per fraction, 5 fractions per week for 6 weeks; PTV-CTV: 54Gy at 1.8Gy per fraction, 5 fractions per week for 6 weeks) with a Temozolomide (TMZ) regimen（75mg/m2 per day during RT）and TTFields therapy during RT. The TTFields therapy started on the day the radiotherapy started.

Treatment:

Device: TTFields

C group

No Intervention group

Description:

All patients received chemoradiotherapy (CRT) ( PTV-GTV: 60Gy at 2.0Gy per fraction, 5 fractions per week for 6 weeks; PTV-CTV: 54Gy at 1.8Gy per fraction, 5 fractions per week for 6 weeks) with a Temozolomide (TMZ) regimen（75mg/m2 per day during RT）